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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K231002
Device Name Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Applicant
Suzhou Endophix Co., Ltd.
# 151, Fengli Rd.
Suzhou,  CN 215000
Applicant Contact Jaun Wu
Correspondent
Suzhou Endophix Co., Ltd.
# 151, Fengli Rd.
Suzhou,  CN 215000
Correspondent Contact Jaun Wu
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/07/2023
Decision Date 06/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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